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    Summary
    EudraCT Number:2005-002711-25
    Sponsor's Protocol Code Number:039SC04253
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-04-20
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2005-002711-25
    A.3Full title of the trial
    Dose finding study of trazodone in the treatment of patients with primary insomnia
    A.4.1Sponsor's protocol code number039SC04253
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorACRAF S.p.A.
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.1.1.1Trade name Minias*OS GTT 20 ML 0,25%
    D.2.1.1.2Name of the Marketing Authorisation holderSchering
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLormetazepam
    D.3.4Pharmaceutical form Oral drops, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLormetazepam
    D.3.9.1CAS number 0000848-75-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2,5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.1.1.1Trade name Trittico 25 mg/ml oral drops, solution
    D.2.1.1.2Name of the Marketing Authorisation holderACRAF S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTrazodone
    D.3.4Pharmaceutical form Oral drops, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTrazodone
    D.3.9.1CAS number 0019794-93-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Insomnia (or insomnia associated with mild non-psychotic psychiatric disorders)
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate in outpatients with primary insomnia the hypnotic efficacy of a two-week treatment period of trazodone 30, 60, or 90 mg once daily at bedtime
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of a two week treatment period followed by six day tapered discontinuation of trazodone 30, 60, or 90 mg once daily at bedtime. To evaluate the hang-over effects of 3 trazodone and lormetazepam dosages.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patients may be enrolled under the following circumstances:
    ·male or female patients with no limitation of race, aged between 18 and 65 years (limits included);
    ·clinical diagnosis of either primary insomnia or insomnia associated with mild non-psychotic psychiatric disorders (DSM-IV code 300.9) based on subjective reporting of current history of insomnia, as defined by DSM-IV (code 307.42), presenting in the last month, at least two of the following characteristics:
    ·predominant complaint of difficulty of initiating or maintaining sleep, or non restorative sleep;
    ·sleep disturbance (or associated daytime fatigue) causing clinically significant distress or impairment in social, occupational, or other important areas of functioning;
    ·frequent (3 or more per night) nocturnal awakenings with difficulty returning to sleep;
    ·Time to Sleep Onset (TSO) > 30 min in at least three nights of the week preceding the enrolment (Visit 2);
    ·Total Sleep Time (TST) of 4-6 hours in at least three nights of the week preceding the enrolment (Visit 2);
    ·Zung Anxiety Scale score < 40
    ·Zung Depression Scale score < 40
    ·normal physical, neurological, and laboratory profile with no acute, chronic, or recurrent conditions that might affect the study;
    ·discontinuation of benzodiazepines or other over-the-counter sleep medication or other psychotropic drugs for 1-2 weeks, depending upon duration of action;
    ·consent to maintain a regular work and activity schedule, avoid naps, consume no alcohol, and have no caffeine after 15:00 hours;
    ·signed and dated informed consent form.
    E.4Principal exclusion criteria
    Patients cannot enter the trial under the following circumstances:
    ·history of occurrence of adverse reactions or known hypersensitivity to the experimental drugs and their eccipients;
    ·history or presence of clinically significant hepatic or renal disease or other medical disease that might compromise the study;
    ·serious respiratory insufficiency, myastenia gravis, narrow angle glaucoma;
    ·myocardial infarction within 6 months prior to start of the treatment;
    ·sleep disturbance occurring exclusively during the course of narcolepsy, breathing-related sleep disorders, circadian sleep disorder, or a parasomnia;
    ·sleep disturbance occurring exclusively during the course of another mental disorder (i.e, major depressive disorder, generalized anxiety disorder, a delirium);
    ·sleep disturbances due to the direct physiological effects of a substance (e.g., a drug of abuse, a medication) or a general medical conditions;
    ·recent history of alcoholism;
    ·regular use of any medication that in the Investigators’ opinion would interfere with the study;
    ·thyroid dysfunction, even if pharmacologically corrected;
    ·clinically significant abnormalities on the pre-study physical examination, vital signs, ECG and laboratory tests;
    ·positive urine drug screen for CNS-active drugs (cocaine, amphetamines, cannabinoids, oppioids);
    ·concomitant diseases that might cause insomnia (i.e., pain sindromes, cardiovascular or gastrointestinal or muscle-skeletal disorders, and urological patologies characterized by nicturia);
    ·pregnancy, lactation, or female of childbearing age with a positive urine pregnancy test result during the screening assessment. Women of childbearing age must use a medically acceptable form of contraception during the entire study period;
    ·participation to another trial involving any investigational drug during the past 60 days.
    The absence of any of the above mentioned inclusion criteria or presence of any of the above mentioned exclusion criteria during the course of the study will result in the withdrawal of the patient.
    E.5 End points
    E.5.1Primary end point(s)
    Primary:to evaluate in outpatients with primary insomnia (or insomnia associated with mild non-psychotic psychiatric disorders) the hypnotic efficacy of a 2-week treatment period of trazodone 30, 60 or 90 mg once daily at bedtime; a control group of patients treated with lormetazepam 1 mg once daily at bedtime is also foreseen
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-04-20. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-03-04
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